The FDA`s highest legal appointment has fluctuated between career staff and political appointees. The new Biden administration could choose to bring in its own senior adviser or do what the Obama administration did in 2012 when it promoted career lawyer Liz Dickinson to permanent chief counsel. „When I took this job, I really thought I was working in relative obscurity from an agency`s operations department in White Oak, Maryland,” Amin said at the conference, referring to FDA headquarters about 10 miles from Washington. „But that turned out to be no further from reality.” Consultants provide legal services to FDA and HHS officials on matters involving FDA-regulated products such as pharmaceuticals, biologics, food, medical devices, cosmetics, veterinary products, radiation emitting products, and tobacco products. These services include, for example, the review and revision of draft and final regulations, final drafts and guides, responses to citizens` petitions, bills, press materials and correspondence. In addition, the consultants advise government officials on complex medical device approvals and safety issues, as well as food safety and nutrition issues. In emergency situations such as foodborne illness outbreaks, new influenza outbreaks or potential bioterrorist attacks, advisors provide legal services essential to an immediate and effective government response. The Office of the Chief Legal Counsel of the FDA consists of approximately 130 lawyers and 20 support staff. It is located at the FDA headquarters in Silver Spring, Maryland, a suburb of Washington, DC. Lawyers in the Office of the Chief Counsel have the opportunity to have an immediate and immediate impact on public health and justice across the country. They advise the FDA on legal matters and represent the agency in court proceedings and administrative hearings.
They participate in civil and criminal cases; draft pleadings, motions and pleadings; and participate in discoveries and studies. Lawyers also advise on the organization`s key programs: drugs, food, biologics, devices, veterinary products, tobacco products and law enforcement. They prepare legal opinions and participate in rule-making procedures, legislative affairs, political deliberations and international negotiations. In addition, lawyers are involved in explaining the agency`s programs to Congress, the regulated industry, and the public. The agency offers a fascinating work environment with a variety of daily challenges. The expanded legal team handled more than 8,000 requests for review or advice, often working around the clock to expedite the development of guidance and other strategic decisions. Amin has led the FDA`s legal advice on key policy initiatives, including the agency`s power to regulate e-cigarettes and combat the opioid crisis. She also defended the agency`s authority — which the Trump administration revoked — to ensure the accuracy of lab-developed Covid-19 tests. The FDA`s senior counsel, Stacy Cline Amin, will resign effective Monday, the agency`s chief announced. „She played a key role in establishing the FDA`s guidelines to ensure scientists could conduct independent scientific reviews of the safety and efficacy of COVID-19 vaccines, and in resolving extraordinarily complex legal issues in the face of this unprecedented global pandemic,” Nashelsky said. During her more than two-year tenure, Amin oversaw the agency`s legal work on high-profile issues such as the agency`s power to regulate e-cigarettes, the government shutdown, and the FDA`s response to the pandemic.
[…] An investigation into corruption at Ghana`s Food and Drug Authority led to the dismissal of the agency`s chief legal officer. Another investigation entitled: „Bongo Scandal”, which revealed fraudulent activities in […] In addition, consultants play an active role in the agency`s Congress-related activities. For example, consultants review written testimony from congressional representatives and congressional correspondence, analyze pending FDA-related legislation, and assist the FDA in responding to requests for technical assistance or other congressional briefings. Consultants help the FDA implement new and old legislation, which often involves complex legal analysis of complex legal regulations. Advisors also participate in FDA interactions with other federal agencies (e.g., USDA, EPA, FTC) and with state health agencies. The advisors also advise FDA officials in their interactions with stakeholders such as the public, healthcare providers and institutions, regulated companies, and associations representing a wide range of stakeholders. The advisers also contribute significantly to the transparency of the authority`s actions through the interpretation and implementation of the Freedom of Information Act, the Federal Advisory Council Act, the Administrative Procedure Act and other administrative activities. After a decade of government service, Amin said she did not initially commit to returning to the legal profession, where she had previously spent time in her legal career at Sullivan & Cromwell LLP and Caplin & Drysdale.
But she was drawn to the company`s „unparalleled expertise” at the intersection of healthcare, life sciences and technology, a Washington office with other former officials, and the company`s commitment to diversity and inclusion, as well as its promotion and leadership with women. Prior to joining the FDA, Amin advised the White House on legal matters related to HHS and served as a trainee attorney at the U.S. Court of Appeals for the Eighth Circuit. But it was his positions as legal counsel on Capitol Hill that developed his keen interest in public health and safety. One of his first investigations as a Senate staffer was the 2012 outbreak of fungal meningitis at a compounding facility in New England, which resulted in 64 deaths and nearly 800 cases in 20 states. Michael R. M. Ward, global head of the firm`s life sciences practice group, said these issues are also critical for many clients. „We see huge synergies with the addition of Stacy to our team. We are delighted to welcome him to the firm. If you are interested in protecting public health, and if you want the satisfaction that comes from public service and working with highly motivated colleagues who are committed to integrity, excellence, respect, and enjoyment in their work, you will find a rewarding career and exciting opportunities for professional growth in the FDA`s legal staff.
Looking ahead, the former FDA`s chief counsel said she expects the Covid-19 pandemic to weigh on the regulatory landscape for some time to come, as manufacturers of new medical devices continue to apply for emergency use authorization and companies with EUAs move to full approvals. „Management appreciates the patience shown by all employees during the disciplinary process. Former FDA Commissioner Scott Gottlieb, who led the agency when it joined, hailed Amin`s time as chief adviser as an „exceptional race.” The FDA is an equal opportunity advocate. For more information about the agency, visit the FDA`s website at www.fda.gov. „I`m so honored to have had the opportunity to lead the FDA`s incredible group of lawyers,” Amin said at the Food and Drug Law Institute`s annual conference, after acknowledging that the meeting would likely be her last public appearance. „I`ve said it before, and I`m really serious, this is the most talented group of dedicated people I`ve ever worked with.” Director, Center for Devices and Radiological Health „Management wishes to inform employees that Ms. Cynthia Dapaah-Ntow, Chief Legal Officer, will no longer be an employee of the FDA effective May 18, 2021. The decision was made after Ms. Cynthia Dapaah-Ntow went through the agency`s internal disciplinary process following allegations of misconduct. Ms. Dapaah-Ntow is captured in the investigative documentary The Returned Bribe by Manasseh Azure Awuni, who negotiates a $200,000 bribe from COA FS`s chief executive.
Great job Manasseh. My mentor mimi darko. The C.E.O of FDB has been confirmed. There are also a lot of questions about the FDA`s authority over lab-developed tests that need to be eliminated, as well as digital health and animal biotechnology, she said. Hi Evans, nice article. In your article, you talked about Professor Samuel Ato Duncan, CEO of the COA. Do you know where he graduated or which university awarded him the professorship? I tried to read some of his publications, but I couldn`t find any. Thank you very much. Great job, brother. May the Lord protect you from your criticism.
According to senior sources, the list will be submitted to the Attorney General`s Office for consultation. David Mednick Associate Chief Counsel for Tobacco Instruments and Integrity Program Review! Integrity! Self-esteem, not net worth. We all need to think about our integrity.